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Model Number SYM2515E |
Device Problems
Migration or Expulsion of Device (1395); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abdominal Pain (1685); Adhesion(s) (1695); Emotional Changes (1831); Fever (1858); Hematoma (1884); Inflammation (1932); Nausea (1970); Nerve Damage (1979); Pain (1994); Pneumonia (2011); Seroma (2069); Vomiting (2144); Hernia (2240); Anxiety (2328); Distress (2329); Numbness (2415); Obstruction/Occlusion (2422); Respiratory Failure (2484); Ascites (2596); Abdominal Distention (2601); Fluid Discharge (2686); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Event Description
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The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a ventral incisional hernia.It was reported that after the implant, the patient experienced mental pain/anguish, pain, disability, impairment, loss of enjoyment of life, defective mesh, and emotional distress.Post-operative patient treatment included medical treatment.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Additional info: b2 (added hospitalization and life threatening), ( ime e2402: "emp hysema, abnormal wbc, potassium, and chloride, ileus, leukocytosis, cord lipoma").Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a ventral incisional hernia.It was reported that after the implant, the patient experienced bulge, abdominal pain, serosanguinous fluid discharge, cord lipoma, pneumonia, acute respiratory failure, fever, nausea, vomiting, emphysema, abnormal wbc, potassium and chloride, ileus, leukocytosis, adhesions, obstruction, recurrence, nerve damage, seroma, inflammation, hematoma, fluid collection, anxiety, numbness, mesh migration, suffering, balled up mesh, mental pain/anguish, pain, disability, impairment, loss of enjoyment of life, defective mesh, and emotional distress.Post-operative patient treatment included ultrasound, procedure for right upper quadrant fluid collection, ultrasound guided right anterior abdominal wall fluid collection aspiration, lap lysis of adhesions, bilateral component separation, transverse abdominis release, ct scan, abdominal x-rays, gastrografin, hospitalization, ng tube placement, iv fluids, iv pain medications, iv antibiotics, additional surgery for hernia repair, closure of posterior rectus sheath defect and placement of overlying retrorectus tissue reinforcement, total parenteral nutrition, physical therapy, medical treatment and hernia repair with new mesh.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a ventral incisional hernia.It was reported that after the implant, the patient experienced adhesions, obstruction, recurrence, nerve damage, seroma, inflammation, hematoma, fluid collection, anxiety, numbness, mesh migration, suffering, balled up mesh, mental pain/anguish, pain, disability, impairment, loss of enjoyment of life, defective mesh, and emotional distress.Post-operative patient treatment included medical treatment and hernia repair with new mesh.
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Search Alerts/Recalls
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